D-0629-2025 Class II Ongoing
FDA drug recall D-0629-2025 was initiated by Atlantic Management Resources Ltd. on Aug 27, 2025 and is designated Class II. Reason for recall: cGMP violations The recall status is ongoing. Affected quantity: 72 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 17, 2025
- Initiation Date
- Aug 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 containers
Product Description
Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
Reason for Recall
cGMP violations
Distribution Pattern
Product was distributed via the internet.
Code Information
Lot # B-02 Batch #: 1087920520 Product # R937 BBE#31-05-21( May 31, 2021) Batch # 1087920920 Product # R937 BBE# 31-05-21 (May 31, 2021)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0629-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026